Cost-effectiveness of Laser Doppler Imaging in Burn Care

NCT01489540 | Completed

• 1 other identifier: 2011-47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Accurate early burn depth assessment is important to determine the optimal treatment. The most applied method to asses burn depth is clinical assessment. This method is the least expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately assess burn depth. The clinical effects, the costs and cost-effectiveness of this device however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably leads to a decrease in wound healing time, in length of hospital stay and in costs. Before the investigators decide to implement LDI in Dutch burn care a study of the clinical effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized controlled trial will be conducted, including all patients with burns of indeterminate depth (burns that are not obviously superficial or full thickness) treated in the Dutch burn centres. In total 200 patients will be included in an 18 months period. The patients are randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler imaging in all patients. The results of the LDI-scan will be provided to the treating clinician in the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and therapeutic decisions, and costs are observed.

Conditions

Burns

Keywords

Burn; Depth; Diagnosis; Laser Doppler Imaging

Outcome Measures

Primary Outcomes (1)

• Wound healing time

  Time to complete wound healing (\>95 % reepithelialisation) and rate of wound healing (% reepithelialisation) at day 14 post burn will be assessed clinically (Bloemen et al., 2011)

  14 days post burn

Secondary Outcomes (4)

• The effect of LDI on patient outcomes: quality of life and scar quality

  3 months post burn

• The effect of LDI on diagnostic and therapeutic decisions

  Until wound healing, circa 2-6 weeks

• The effect of LDI on total (medical and non medical) costs

  From injury until 3 months post burn

• The cost-effectiveness of LDI compared to the standard diagnostic strategy

  From injury until 3 months post burn

Study Arms (2)

new diagnostic strategy

ACTIVE COMPARATOR

Combination of laser Doppler imaging and clinical assessment of burn depth

Device: laser Doppler imager (Moor)

current diagnostic strategy

NO INTERVENTION

Clinical assessment of burn depth

Interventions

laser Doppler imager (Moor) DEVICE

The laser Doppler imager measures the blood flow of the skin/burn

Also known as: Laser Doppler Imager, Moor Instruments, Moor LDI Burn Imager

new diagnostic strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute burns of indeterminate depth (=intermediate depth, not obviously superficial or full thickness) at presentation
• Outpatient treatment or admission in one of the three Dutch burn centres
• Presentation within 5 days post burn

You may not qualify if:

• A presence of both burns of indeterminate depth and full thickness at presentation
• Patients with peri-orbital facial burns, in which the eyes are unable to shield
• Patients or their next of kin if they are under aged or temporary incompetent who can not be expected to give informed consent e.g. because of cognitive dysfunction or poor Dutch proficiency.
• Patients with a TBSA burned \> 20%

Sponsors & Collaborators

• Association of Dutch Burn Centres: lead
• Dutch Burns Foundation: collaborator
• Stichting Nuts Ohra: collaborator

Study Sites (3)

Red Cross Hospital

Beverwijk, North Holland, 1940 EB, Netherlands

Location

Martini Hospital

Groningen, Provincie Groningen, 9700 RM, Netherlands

Location

Maasstad Hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

Related Publications (14)

• Kim LH, Ward D, Lam L, Holland AJ. The impact of laser Doppler imaging on time to grafting decisions in pediatric burns. J Burn Care Res. 2010 Mar-Apr;31(2):328-32. doi: 10.1097/BCR.0b013e3181d0f572.

  PMID: 20182369 BACKGROUND

• Monstrey S, Hoeksema H, Verbelen J, Pirayesh A, Blondeel P. Assessment of burn depth and burn wound healing potential. Burns. 2008 Sep;34(6):761-9. doi: 10.1016/j.burns.2008.01.009. Epub 2008 Jun 3.

  PMID: 18511202 BACKGROUND

• Jeng JC, Bridgeman A, Shivnan L, Thornton PM, Alam H, Clarke TJ, Jablonski KA, Jordan MH. Laser Doppler imaging determines need for excision and grafting in advance of clinical judgment: a prospective blinded trial. Burns. 2003 Nov;29(7):665-70. doi: 10.1016/s0305-4179(03)00078-0.

  PMID: 14556723 BACKGROUND

• Engrav LH, Heimbach DM, Reus JL, Harnar TJ, Marvin JA. Early excision and grafting vs. nonoperative treatment of burns of indeterminant depth: a randomized prospective study. J Trauma. 1983 Nov;23(11):1001-4. doi: 10.1097/00005373-198311000-00007.

  PMID: 6355500 BACKGROUND

• Herndon DN, Barrow RE, Rutan RL, Rutan TC, Desai MH, Abston S. A comparison of conservative versus early excision. Therapies in severely burned patients. Ann Surg. 1989 May;209(5):547-52; discussion 552-3. doi: 10.1097/00000658-198905000-00006.

  PMID: 2650643 BACKGROUND

• Bloemen MC, van Zuijlen PP, Middelkoop E. Reliability of subjective wound assessment. Burns. 2011 Jun;37(4):566-71. doi: 10.1016/j.burns.2011.02.004. Epub 2011 Mar 8.

  PMID: 21388743 BACKGROUND

• Bouillon B, Kreder HJ, Eypasch E, Holbrook TL, Kreder HJ, Mayou R, Nast-Kolb D, Pirente N, Schelling G, Tiling T, Yates D; MI Consensus Group. Quality of life in patients with multiple injuries--basic issues, assessment, and recommendations. Restor Neurol Neurosci. 2002;20(3-4):125-34.

  PMID: 12454361 BACKGROUND

• Raat H, Landgraf JM, Oostenbrink R, Moll HA, Essink-Bot ML. Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample. Qual Life Res. 2007 Apr;16(3):445-60. doi: 10.1007/s11136-006-9134-8. Epub 2006 Nov 17.

  PMID: 17111231 BACKGROUND

• Draaijers LJ, Botman YA, Tempelman FR, Kreis RW, Middelkoop E, van Zuijlen PP. Skin elasticity meter or subjective evaluation in scars: a reliability assessment. Burns. 2004 Mar;30(2):109-14. doi: 10.1016/j.burns.2003.09.003.

  PMID: 15019116 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Kreis RW, Middelkoop E, van Zuijlen PP. Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation? Burns. 2004 Mar;30(2):103-7. doi: 10.1016/j.burns.2003.09.029.

  PMID: 15019115 BACKGROUND

• van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.

  PMID: 21598065 BACKGROUND

• Monstrey SM, Hoeksema H, Baker RD, Jeng J, Spence RS, Wilson D, Pape SA. Burn wound healing time assessed by laser Doppler imaging. Part 2: validation of a dedicated colour code for image interpretation. Burns. 2011 Mar;37(2):249-56. doi: 10.1016/j.burns.2010.08.013. Epub 2010 Nov 16.

  PMID: 21084164 BACKGROUND

• Hop MJ, Stekelenburg CM, Hiddingh J, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI Study Group. Cost-Effectiveness of Laser Doppler Imaging in Burn Care in The Netherlands: A Randomized Controlled Trial. Plast Reconstr Surg. 2016 Jan;137(1):166e-176e. doi: 10.1097/PRS.0000000000001900.

  PMID: 26710049 DERIVED

• Hop MJ, Hiddingh J, Stekelenburg C, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI study group. Cost-effectiveness of laser Doppler imaging in burn care in the Netherlands. BMC Surg. 2013 Feb 1;13:2. doi: 10.1186/1471-2482-13-2.

  PMID: 23369360 DERIVED

MeSH Terms

Conditions

Burns; Disease

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margriet E Baar, PhD

  Associaton of Dutch Burns Centres

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 9, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: September 19, 2013

Record last verified: 2011-12

Locations

NL (3)